[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period crossover bioequivalence study of cefprozil tablets in Chinese healthy participants under fasting/postprandial conditions

主要目的：健康参与者空腹/餐后状态下，口服单剂量头孢丙烯片（受试制剂T，深圳立健药业有限公司生产，规格：0.25g/片）与头孢丙烯片（参比制剂R，Lupin Limited生产，规格：0.25g/片）后，考察空腹/餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂头孢丙烯片和参比制剂头孢丙烯片在健康参与者中的安全性。

[Translation]

Primary objective: To investigate the absorption rate and extent of the test preparation and the reference preparation under fasting/postprandial conditions after oral administration of a single dose of cefprozil tablets (test preparation T, produced by Shenzhen Lijian Pharmaceutical Co., Ltd., specification: 0.25g/tablet) and cefprozil tablets (reference preparation R, produced by Lupin Limited, specification: 0.25g/tablet) to healthy participants, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy participants.

Start Date11 Apr 2025

Sponsor / Collaborator

Shenzhen Lijian Pharmaceutical Co. Ltd.

CTR20244664

/ CompletedNot Applicable

头孢托仑匹酯颗粒在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of cefditoren pivoxil granules in healthy subjects under fasting/fed conditions

主要目的：健康受试者空腹/餐后状态下，口服单剂量头孢托仑匹酯颗粒（受试制剂T，深圳立健药业有限公司生产，规格：50mg（效价）/0.5g/袋）与头孢托仑匹酯颗粒（参比制剂R，Meiji Seika Pharma Co., Ltd.生产，规格：50mg（效价）/0.5g/袋）后，本次试验考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂头孢托仑匹酯颗粒和参比制剂头孢托仑匹酯颗粒在健康受试者中的安全性。

[Translation]

Primary objective: After oral administration of a single dose of Cefditoren Pivoxil Granules (test preparation T, produced by Shenzhen Lijian Pharmaceutical Co., Ltd., specification: 50mg (potency)/0.5g/bag) and Cefditoren Pivoxil Granules (reference preparation R, produced by Meiji Seika Pharma Co., Ltd., specification: 50mg (potency)/0.5g/bag) to healthy subjects in fasting/postprandial state, this study investigated the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions, and evaluated whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation Cefditoren Pivoxil Granules and the reference preparation Cefditoren Pivoxil Granules in healthy subjects.

Start Date07 Jan 2025

Sponsor / Collaborator

Shenzhen Lijian Pharmaceutical Co. Ltd.

CTR20212798

/ CompletedNot Applicable

头孢克肟干混悬剂在中国健康受试者空腹/餐后状态下，随机、开放、两制剂、单剂量、两序列、两周期交叉的生物等效性试验

[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period crossover bioequivalence study of cefixime dry suspension in Chinese healthy volunteers under fasting/fed conditions

主要目的：中国健康受试者空腹/餐后状态下，口服单剂量头孢克肟干混悬剂（Cefixime for Suspension，受试制剂T，深圳立健药业有限公司生产，规格：0.1 g）与头孢克肟干混悬剂（Cefixime for Suspension，参比制剂R，持证商：Lupin Pharmaceuticals, Inc.，规格：100 mg/5 mL）进行生物等效性试验，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂头孢克肟干混悬剂和参比制剂头孢克肟干混悬剂在健康受试者中的安全性。

[Translation]

Primary objective: To conduct a bioequivalence study of a single oral dose of Cefixime for Suspension (test preparation T, produced by Shenzhen Lijian Pharmaceutical Co., Ltd., specification: 0.1 g) and Cefixime for Suspension (reference preparation R, licensee: Lupin Pharmaceuticals, Inc., specification: 100 mg/5 mL) in Chinese healthy subjects under fasting/postprandial conditions, to investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation Cefixime for Suspension and the reference preparation Cefixime for Suspension in healthy subjects.

Start Date28 Dec 2021

Sponsor / Collaborator

Shenzhen Lijian Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shenzhen Lijian Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Shenzhen Lijian Pharmaceutical Co. Ltd.

100 Deals associated with Shenzhen Lijian Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Shenzhen Lijian Pharmaceutical Co. Ltd.

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